MaxiTears Contacts PF

K182984 · Omnivision AG · MRC · Jul 24, 2019 · Ophthalmic

Device Facts

• Record ID: K182984
• Device Name: MaxiTears Contacts PF
• Applicant: Omnivision AG
• Product Code: MRC · Ophthalmic
• Decision Date: Jul 24, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5918
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MaxiTears® CONTACTS PF eye drops have been formulated for use with both soft and rigid gas permeable (RGP) contact lenses, to rewet lenses before insertion and lubricate lenses during wear. It also relieves minor irritation, discomfort, dryness, blurring and itchiness, which may occur while wearing your lenses.

Device Story

MaxiTears CONTACTS PF is a sterile, isotonic, preservative-free, medium-viscous aqueous solution containing sodium hyaluronate as a humectant. Supplied in single-use low-density polyethylene (LDPE) ampoules; intended for OTC use by contact lens wearers. Device functions via physical mode of action to moisturize and lubricate the ocular surface and contact lenses. User applies drops directly to the eye or lens to alleviate symptoms of dryness, discomfort, and irritation caused by environmental factors or lens wear. No active ingredients; preservative-free formulation benefits users with history of preservative allergies. Device is discarded after single use.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical performance testing including biocompatibility (ISO 10993), lens compatibility (ISO 1198, ISO 18369), shelf-life stability (ISO 13212), and usability engineering (IEC 62366).

Technological Characteristics

Sterile, isotonic, buffered (pH 6.8-7.6) aqueous solution. Contains sodium hyaluronate. Preservative-free. Packaging: single-use LDPE ampoules. Sterilization: aseptic filling via 1.2µm polypropylene filter and blow-fill-seal process at 160-190°C. Biocompatibility per ISO 10993 series. Osmolality: 270-330 mosmol/kg.

Indications for Use

Indicated for soft and rigid gas permeable (RGP) contact lens wearers to rewet lenses before insertion, lubricate lenses during wear, and relieve minor irritation, discomfort, dryness, blurring, and itchiness associated with lens wear.

Regulatory Classification

Identification

A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.

Special Controls

*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”

Predicate Devices

• blink™ CL Lubricant Eye Drops (K032030)

Submission Summary (Full Text)

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July 24, 2019

Omnivision AG % Oliver Eikenberg, PhD Senior Consultant, QA/RA Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746

Re: K182984

Trade/Device Name: MaxiTears CONTACTS PF Regulation Number: 21 CFR 886.5918 Regulation Name: Rigid Gas Permeable Contact Lens Care Products Regulatory Class: Class II Product Code: MRC, LPN Dated: June 14, 2019 Received: June 17, 2019

Dear Dr. Eikenberg:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K182984

Device Name MaxiTears® CONTACTS PF

#### Indications for Use (Describe)

MaxiTears® CONTACTS PF eye drops have been formulated for use with both soft and rigid gas permeable (RGP) contact lenses, to rewet lenses before insertion and lubricate lenses during wear. It also relieves minor irritation, discomfort, dryness, blurring and itchiness, which may occur while wearing your lenses.

| Type of Use (Select one or both, as applicable) | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|-------------------------------------------------------------|--------------------------------------------|------------------------------------------------------------------------|
| <table border="0"><tr><td><input type="checkbox"/></td><td>Research Use Only; RUO-Not for use in Diagnostic Procedures</td></tr><tr><td><input checked="checked" type="checkbox"/></td><td>For <i>In Vitro</i> Diagnostic Use; IVD-Subject to Certain Limitations</td></tr></table> | <input type="checkbox"/> | Research Use Only; RUO-Not for use in Diagnostic Procedures | <input checked="checked" type="checkbox"/> | For <i>In Vitro</i> Diagnostic Use; IVD-Subject to Certain Limitations |
| <input type="checkbox"/> | Research Use Only; RUO-Not for use in Diagnostic Procedures | | | |
| <input checked="checked" type="checkbox"/> | For <i>In Vitro</i> Diagnostic Use; IVD-Subject to Certain Limitations | | | |

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

## MaxiTears CONTACTS PF

# K182984

#### 1. Submission Sponsor

Omnivision AG Zentralstrasse 100 Neuhausen am Rheinfall, Schaffhausen CH-8212 Switzerland Contact: Joachim Kolter, Management Representative (QMB)

#### 2. Submission Correspondent

Emergo Global Consulting, LLC

2500 Bee Cave Road

Building 1, Suite 300

Austin, TX 78746

Office Phone: [phone]

Contact: Oliver Eikenberg, PhD

Title: Senior Consultant, Quality & Regulatory Affairs

#### 3. Date Prepared

07/16/2019

#### 4. Device Identification

| Trade/Proprietary Name: | MaxiTears CONTACTS PF |
|-------------------------|-------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Lens Care products |
| Classification Name: | Rigid Gas Permeable (RGP) Contact Lens Care Products<br>Soft (hydrophilic) Contact Lens Care Products |
| Regulation Number: | §886.5918 , §886.5928 |
| Product Code: | MRC, LPN |
| Device Class: | Class II |
| Classification Panel: | Ophthalmic |

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## 5. Legally Marketed Predicate Device(s)

PREDICATE: K032030, blink™ CL Lubricant Eye Drops, manufactured by Advanced Medical Optics, CA, USA

## 6. Indication for Use Statement

MaxiTears® CONTACTS PF eve drops have been formulated for use with both soft and rigid gas permeable (RGP) contact lenses, to rewet lenses before insertion and lubricate lenses during wear. It also relieves minor irritation, discomfort, dryness, blurring and itchiness, which may occur while wearing your lenses.

## 7. Device Description

The MaxiTears CONTACTS PF are ready-to-use, isotonic, sterile eye contact lens care products (lubricants) intended to moisturize and lubricate the lens drops in eyes to reduce minor symptoms of dry eyes such as burning or itching. The intended use of these contact lens rewetting solutions is to alleviate the symptoms of dryness, discomfort, and minor irritation caused by ocular fatigue induced by the wearing of contact lenses, for example, by environmental conditions (dust, smoke, dry heat, air conditioning, wind, cold) tiredness or extended computer screen use. The MaxiTears CONTACTS PF solution can be used with all types of contact lenses, except contact lenses manufactured from Efrofilcon A, and are intended for repeated use over an extended period of time.

The MaxiTears CONTACTS PF solution it to be introduced to the US-market as an Over the Counter (OTC) medical device similar to other 510k-cleared lens drop lubricants (and identical to predicate Blink CL Lubricant Eve Drops K032030), sold as OTC medical device in retail outlets and through the internet.

OmniVision AG is offering the MaxiTears CONTACTS PF solution as Over the Counter device:

- MaxiTears' CONTACTS PF is a medium viscous preservative-free solution packaged in single-use . ampoules (single-dose units -SDU). They are supplied as single-dose unit plastic ampoules designed to administer one drop and then to be discarded. They are indicated for users with a known history of allergy to preservatives and those who wear contact lenses.
### 8. Substantial Equivalence Discussion

The following table compares the "MaxiTears® CONTACTS PF" to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject devices do not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

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| | Subject Device | Predicate Device | Device Comparison |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Omnivision AG (SWITZERLAND) | Advanced Medical Optics, (USA) | |
| Trade Name | MaxiTears® CONTACTS PF | blink™ CL Lubricant Eye Drops | |
| 510(k) Number | K182984 | K032030 | NA |
| Product Code | MRC, LPN | MRC, LPN | Same |
| Regulation Number | 21 CFR 886.5918 Rigid Gas Permeable (RGP) Contact Lens Care Products<br>21 CFR 886.5928 Soft (hydrophilic) Contact Lens Care Products | | Same |
| Regulation Panel | Ophthalmic | | Same |
| Principle of<br>Operation | Physical mode, Works inside of the eye providing moisturization and<br>lubrication for Soft & RGP Contact Lenses | | Same |
| Over the Counter Use | Yes | Yes | Same |
| Multi or Single-Use | Single-use variants | Multi-use only | Similar |
| Variants | MaxiTears CONTACTS PF | blink™C L Lubricant Eye Drops | Similar, different<br>packaging |
| Indications for Use | MaxiTears® CONTACTS PF eye drops<br>have been formulated for use with both<br>soft and rigid gas permeable (RGP)<br>contact lenses, to rewet lenses before<br>insertion and lubricate lenses during<br>wear. It also relieves minor irritation,<br>discomfort, dryness, blurring and<br>itchiness, which may occur while<br>wearing your lenses. | Use blink™ CL Lubricant Eye Drops<br>to lubricate and rewet soft and rigid<br>gas permeable (RGP) contact lenses;<br>to help relieve dryness, irritation<br>and discomfort that may be<br>associated with lens wear; and to<br>cushion lenses by placing a drop on<br>the lens prior to application on the<br>eye. | Similar, the<br>indications for use<br>are both for eye<br>lubricant on soft<br>and rigid gas<br>permeable lenses |
| Clinical Indication | Relief of symptoms of eye dryness and irritation due to environmental<br>conditions of the eye caused by Contact Lenses | | Same |
| Volume / Bottle | 5x, 20x or 60x 0.4 mL , single-use<br>vials | 2 mL (0.06 fl oz), multi-use<br>10 mL (0.34 fl oz) multi-use | Similar |
| Overall Design | Sterile, Buffered, Isotonic, Aqueous<br>Solution | Sterile, Buffered, Isotonic, Preserved<br>Aqueous Solution | Similar |
| Appearance | Clear, coloriess solution packaged in<br>single-use plastic vials (single dose<br>units) | Clear, colorless solution packaged in<br>plastic bottles with controlled dropper<br>tips | Same |
| Active ingredients | No | No | Same |
| Preserved | No | OcuPure (Oxychloro Complex 0.005 %) | NA |
| Humectant | Sodium hyaluronate | Sodium hyaluronate | Same |
| Osmolality | 270-330 mosmol/kg | 267 mosmol/kg | Similar |
| Buffered | Yes, pH 6.8-7.6 | Yes, pH 7.2 | Similar |
| Sterile | Yes, aseptic filling | Yes, aseptic filling | Same |
| Shelf Life | 2 years | > 9 month<br>45 days after opening | Similar |
| Biocompatibility | Yes, ISO 10993 series | Yes, ISO 10993 series | Same |

## Table 5A – Comparison of Characteristics

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#### 9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of MaxiTears CONTACTS PF and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Omnivision AG completed a number of non-clinical performance tests. The MaxiTears CONTACTS PF meets all the requirements for overall design, sterilization and biocompatibility results confirming that the design output meets the design inputs and specifications for the device.

The MaxiTears CONTACTS PF passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:

- Biocompatibility evaluation and biocompatibility testing of MaxiTears CONTACTS PF lens drop . solutions for patient-contacting materials including chemical characterization, genotoxicity, cytotoxicity, sensitization and irritation reactivity, subacute and systemic toxicity per ISO 10993-1, 3, 5, 10, 11, 12, 17, 18 ; PASSED all testing
- Cleaning and Sterilization Testing MaxiTears CONTACTS PF lens drop solutions are not sterilized in . their final packaging. The sterile bulk solution is stored under aseptic conditions within the storage tank and then for the filling process pushed through a sterile polypropylene filter 1.2µm to the sterilized blow-fill-machine under sterile nitrogen pressure. The sterility of the final solution is preserved by an overpressure sterile nitrogen flow. The filling is performed into natural plastic pellets, made of transparent LDPE, which were extruded at temperatures between 160 and 190 ℃. The molds which leave the extruder, immediately transformed into the 0.4ml Single Dose Unit (SDU)-blocks for MaxiTears CONTACTS PF. The blown SDU are sterile due to the high temperature applied. The devices are classified as Established Category A per the FDA Guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". Sterility tests are performed according USP39-NF34 <71>; PASSED all testing
- In vitro lens compatibility testing testing demonstrates physical product compatibility from . MaxiTears CONTACTS PF lens care solutions with both soft (hydrophilic) and RGP contact lenses according ISO 1198 and ISO 18369-2, -3; PASSED all testing
- . Shelf Life Testing - shelf life determination is based on real time as well as open vial (in-use) stability studies of the MaxiTears CONTACTS PF lens drop solutions performed in compliance with ICH guidance document Q1A and with ISO 13212:2014 Ophthalmic optics -- Contact lens care products -- Guidelines for determination of shelf-life; PASSED all testing
- Storage and Transport Testing include transport validation under routine conditions with different lots . of manufactured MaxiTears CONTACTS PF assembled in different packaging variants to maintain integrity through normal shipping and handling; PASSED all testing
- Usability engineering testing per IEC 62366; PASSED all testing
- Risk Management per ISO 14971 and EN ISO 14971; all requirements were met and risks reduced as . far as possible.

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#### 10. Clinical Performance Data

There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. This type of device, including the predicate devices, have been on the market for many years with proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

#### 11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device.

It has been shown in this 510(k) submission that the difference between the MaxiTears® CONTACTS PF and the predicate device blink™ CL Lubricant Eye Drops does not raise any questions regarding its safety and effectiveness. Technological product characteristics, performance testing and compliance with voluntary standards, demonstrate that the MaxiTears® CONTACTS PF are substantially equivalent to the relevant aspects of the predicate device in terms of design, components, materials, of operation, performance characteristics, and intended use.

The MaxiTears CONTACTS PF, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.